MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A— 510(k) K053566

Name: FDA 510(k) clearance K053566
Creator: U.S. Food and Drug Administration
Published: 2006-02-15

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K053566 for MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A, Substantially Equivalent on 2006-02-15. Applicant: Diazyme Laboratories. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code MZV
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2005-12-22
Decision date: 2006-02-15
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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